Class 2 Device Recall Manifold Set

• Date Initiated by Firm: April 21, 2022
• Create Date: May 27, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1143-2022
• Recall Event ID: 90032
• Product Classification: Set, administration, for peritoneal dialysis, disposable - Product Code KDJ
• Product: 5 Prong Manifold Set (with Luer Connectors)
• Code Information: Product code: R5C4427; UDI: 00085412008691; Lot Number: H17D26065 (exp. date: 04/26/2022), Lot Number: H17I18046 (exp. date: 09/18/2022), Lot Number: H18C20051 (exp. date:03/20/2023), Lot Number: H19J24041 (exp. date:10/24/2024)
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 847-948-4770
• Manufacturer Reason for Recall: Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
• FDA Determined Cause: No Marketing Application
• Action: An Urgent Medical Device Recall communication was sent to affected peritoneal dialysis centers via U.S.P.S., first class mail on 04/21/2022. Instructions within the communication request customers to locate and return any unused affected product codes and lots from their facility, contact Baxter Healthcare Center for Service to arrange for return and credit at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday, and acknowledge the receipt of this notification by completing a reply form on the customer portal or by returning a reply form in the enclosed pre-addressed stamped envelope. The home patient letter was sent on Tuesday, April 26, 2022, via USPS first-class mail.
• Quantity in Commerce: 180 units
• Distribution: US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.